UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029454 |
|---|---|
| Receipt number | R000033380 |
| Scientific Title | Examination of glucose variability using CGM on elder type2 diabetic patiants taking oral hypoglycemic agent |
| Date of disclosure of the study information | 2017/10/07 |
| Last modified on | 2019/01/16 09:42:20 |
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Basic information
Public title
Examination of glucose variability using CGM on elder type2 diabetic patiants taking oral hypoglycemic agent
Acronym
Examination of glucose variability using CGM on elder type2 diabetic patiants taking oral hypoglycemic agent
Scientific Title
Examination of glucose variability using CGM on elder type2 diabetic patiants taking oral hypoglycemic agent
Scientific Title:Acronym
Examination of glucose variability using CGM on elder type2 diabetic patiants taking oral hypoglycemic agent
Region
| Japan |
Condition
Condition
Type2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective is to investigate the good level of HbA1c and combination of oral hypoglycemic agent, without including hypoclycemia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of hypoglycemia
time of hypoglycemia
(hypoglycemia:below 70mg/dl)
Key secondary outcomes
frequency of hyperglycemia
time of hyperglycemia
(hyperglycemia:180mg/dl or more)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
outpatient
type2 diabetes mellitus
65 years old and more
HbA1c level is below 8% on recent 3 months
Patients taking oral hypoglycemic agent, continuing it for 6 months and more, not changing it recent 3 months
Patients consented to participate in this study
Key exclusion criteria
using insulin
using GLP1 analogue
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Odawara |
Organization
Tokyo Medical University
Division name
Diabetology, Metabolism, and Endocrinology
Zip code
Address
6-7-1 Nishishinjuku Shinjuku-ku Tokyo Japan
TEL
+81-3-3342-6111
odawara@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junpei Shikuma |
Organization
Tokyo Medical University
Division name
Diabetology, Metabolism, and Endocrinology
Zip code
Address
6-7-1 Nishishinjuku Shinjuku-ku Tokyo Japan
TEL
+81-3-3342-6111
Homepage URL
inugumitoui@yahoo.co.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 16 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 16 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 16 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2017 | Year | 10 | Month | 06 | Day |
Last modified on
| 2019 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033380
